Baby Gorilla®/Gorilla® Plating System P50-353-3570

GUDID 00889795100399

R3CON Locking Screw, Ø3.50 x 70mm

PARAGON 28, INC.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00889795100399
• NIH Device Record Key: 0bebbe3c-954e-48d1-9f22-eb8d3dee9430
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Baby Gorilla®/Gorilla® Plating System
• Version Model Number: P50-353-3570
• Catalog Number: P50-353-3570
• Company DUNS: 042961576
• Company Name: PARAGON 28, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889795100399 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190365

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00889795100399]

Moist Heat or Steam Sterilization

[00889795100399]

Moist Heat or Steam Sterilization

[00889795100399]

Moist Heat or Steam Sterilization

[00889795100399]

Moist Heat or Steam Sterilization

[00889795100399]

Moist Heat or Steam Sterilization

[00889795100399]

Moist Heat or Steam Sterilization

[00889795100399]

Moist Heat or Steam Sterilization

[00889795100399]

Moist Heat or Steam Sterilization

[00889795100399]

Moist Heat or Steam Sterilization

[00889795100399]

Moist Heat or Steam Sterilization

[00889795100399]

Moist Heat or Steam Sterilization

[00889795100399]

Moist Heat or Steam Sterilization

[00889795100399]

Moist Heat or Steam Sterilization

[00889795100399]

Moist Heat or Steam Sterilization

[00889795100399]

Moist Heat or Steam Sterilization

[00889795100399]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-23
• Device Publish Date: 2020-12-15

On-Brand Devices [Baby Gorilla®/Gorilla® Plating System]

• 00889795100573: R3CON Non-Locking Screw, Ø4.20 x 58mm
• 00889795100566: R3CON Non-Locking Screw, Ø4.20 x 56mm
• 00889795100559: R3CON Non-Locking Screw, Ø4.20 x 54mm
• 00889795100542: R3CON Non-Locking Screw, Ø4.20 x 52mm
• 00889795100535: R3CON Non-Locking Screw, Ø4.20 x 45mm
• 00889795100528: R3CON Non-Locking Screw, Ø4.20 x 8mm
• 00889795100511: R3CON Locking Screw, Ø4.20 x 58mm
• 00889795100504: R3CON Locking Screw, Ø4.20 x 56mm
• 00889795100498: R3CON Locking Screw, Ø4.20 x 54mm
• 00889795100481: R3CON Locking Screw, Ø4.20 x 52mm
• 00889795100474: R3CON Locking Screw, Ø4.20 x 45mm
• 00889795100467: R3CON Locking Screw, Ø4.20 x 8mm
• 00889795100450: R3CON Non-Locking Screw, Ø3.50 x 58mm
• 00889795100443: R3CON Non-Locking Screw, Ø3.50 x 56mm
• 00889795100436: R3CON Non-Locking Screw, Ø3.50 x 54mm
• 00889795100429: R3CON Non-Locking Screw, Ø3.50 x 52mm
• 00889795100412: R3CON Non-Locking Screw, Ø3.50 x 45mm
• 00889795100405: R3CON Non-Locking Screw, Ø3.50 x 8mm
• 00889795100399: R3CON Locking Screw, Ø3.50 x 70mm
• 00889795100382: R3CON Locking Screw, Ø3.50 x 65mm
• 00889795100375: R3CON Locking Screw, Ø3.50 x 60mm
• 00889795100368: R3CON Locking Screw, Ø3.50 x 58mm
• 00889795100351: R3CON Locking Screw, Ø3.50 x 56mm
• 00889795100344: R3CON Locking Screw, Ø3.50 x 55mm
• 00889795100337: R3CON Locking Screw, Ø3.50 x 54mm
• 00889795100320: R3CON Locking Screw, Ø3.50 x 52mm
• 00889795100313: R3CON Locking Screw, Ø3.50 x 45mm
• 00889795100306: R3CON Locking Screw, Ø3.50 x 8mm
• 00889795097491: AVITRAC™ Core, MTP Reamer, Ø13 mm
• 00889795097484: AVITRAC™ Core, MTP Reamer, Ø11 mm
• 00889795097477: AVITRAC™ Core, MTP Reamer, Ø9 mm
• 00889795054210: Precision Guide, Subtalar Joint, Guide Arm, Left
• 00889795054203: Precision Guide, Subtalar Joint, Guide Arm, Right
• 00889795053374: Over Drill, 5.2 x 120mm, Solid, AO
• 00889795053367: Over Drill, 4.5 x 120mm, Solid, AO
• 00889795053350: Drill, 3.6 x 160mm, Solid, Measuring, Long, AO
• 00889795053343: Drill, 3.1 x 160mm, Solid, Measuring, Long, AO
• 00889795053336: Drill, 2.8 x 160mm, Solid, Measuring, Long, AO
• 00889795053329: Drill, 2.4 x 160mm, Solid, Measuring, Long, AO
• 00889795053213: Lateral TTC Plate, Long, Right
• 00889795053206: Lateral TTC Plate, Standard, Right
• 00889795053183: Lateral TT Plate, Standard, Right
• 00889795053169: Lateral TTC Plate, Long, Left
• 00889795053152: Lateral TTC Plate, Standard, Left
• 00889795053138: Lateral TT Plate, Standard, Left
• 00889795053022: Tap, Double Lead, 5.2mm
• 00889795053015: Tap, Double Lead, 4.5mm
• 00889795052087: Gorilla, Precision Guide, Straddle, Guide Jig, U-Configuration
• 00889795051868: Morselizing Bone Graft Harvester, AO, 10mm
• 00889795051844: Morselizing Bone Graft Harvester, AO, 8mm